ISRCTN87195453进行中（未招募）未知
Randomised controlled trial of topical combination therapy chlorhexidine 0.2% and natamycin 5% versus topical natamycin 5% alone for fungal keratitis in East Africa
ondon School of Hygiene & Tropical Medicine0 个研究点目标入组 358 人开始时间: 2020年8月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 358
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute microbial keratitis characterised by:
- •1.1 Corneal epithelial ulceration >1 mm diameter
- •1.2 Corneal stromal infiltrate
- •1.3 Acute inflammation: e.g. conjunctival injection, anterior chamber inflammatory cells, hypopyon
- •2. Filamentous fungal hyphae visualised on smear microscopy and/or in vivo confocal microscopy
- •3. Agree to be randomised to either treatment arm and able to give informed consent
- •4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months
- •5. Adults (18 years and older)
排除标准
- •Current exclusion criteria as of 08/09/2021:
- •1. Unwilling to participate in trial or attend follow-up
- •2. Aged less than 18 years
- •3. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain. 4. Breast feeding: selfreported
- •5. No light perception in the affected eye
- •6. Fellow eye visual acuity <6/60
- •7. Acanthamoebic infection visualised by smear microscopy or IVCM
- •8. Clinical evidence of herpetic keratitis
- •9. Known allergy to study medication (including preservatives)
- •10. Previous penetrating keratoplasty in the affected eye
- •11. Bilateral corneal ulcers
- •12. Nationals of another country
- •13. Very severe ulcers warranting immediate evisceration or conjunctival flap
- •14. Fungal Endophthalmitis
- •Previous exclusion criteria:
- •1. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain
- •2. Breast feeding: self-reported
- •3. Prior topical anti-fungal treatment
- •4. No light perception in the affected eye
- •5. Fellow eye visual acuity <6/60
- •6. Acanthamoebic infection visualised by smear microscopy or IVCM
- •7. Clinical evidence of herpetic keratitis
- •8. Known allergy to study medication (including preservatives)
- •9. Previous penetrating keratoplasty in the affected eye
- •10. Bilateral corneal ulcers
- •11. Very severe ulcers warranting immediate evisceration or conjunctival flap
- •12. Fungal Endophthalmitis
研究者
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